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US Department of Justice
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Generated: July 23, 2017

DrugPatentWatch Database Preview

QSYMIA Drug Profile

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What is the patent landscape for Qsymia, and when can generic versions of Qsymia launch?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in twenty-six countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Summary for Tradename: QSYMIA

Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list8
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:QSYMIA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-004Jul 17, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-003Jul 17, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-003Jul 17, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-003Jul 17, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-003Jul 17, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-002Jul 17, 2012► Subscribe► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-003Jul 17, 2012► Subscribe► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-001Jul 17, 2012► Subscribe► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-004Jul 17, 2012► Subscribe► Subscribe
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Paragraph IV activity for: QSYMIA

Drugname Dosage Strength RLD Submissiondate
phentermine hydrochloride and topiramateExtended-release Capsules3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mgQsymia7/18/2013

Non-Orange Book Patents for Tradename: QSYMIA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,802,636Combination therapy for treatment of sleep apnea► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: QSYMIA

Country Document Number Estimated Expiration
South Africa201008839► Subscribe
Japan5752595► Subscribe
Mexico2010013505► Subscribe
World Intellectual Property Organization (WIPO)2009152189► Subscribe
Slovakia180598► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Healthtrust
Julphar
Cerilliant
US Army
Moodys
Johnson and Johnson
Argus Health
McKesson
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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